NEW Keiki Family Based Intervention to Combat Childhood Obesity
NCT ID: NCT02691039
Last Updated: 2019-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
213 participants
OBSERVATIONAL
2014-03-31
2018-12-31
Brief Summary
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Detailed Description
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* Past medical history
* Obesity-related Medical co-morbidities (HTN, hyperlipidemia, e.g.)
* Lab values (fasting lipids, glucose, LFTs, HbA1c)
* Anthropometric data (ht, weight, BMI) and select vital signs (BP, HR)
* Fitness testing data
* Demographic data (age, gender, ethnicity, socioeconomic status, geographical address)
* Answers to a lifestyle, attitudes, and health habits survey
* Answers to a program survey
* Contact information for follow up
For participating family members (parents, grandparents, siblings, e.g.) this data base will contain information related to the following:
* Past medical history
* Obesity-related Medical co-morbidities (HTN, hyperlipidemia, e.g.)
* Anthropometric data (ht, weight, BMI) and select vital signs (BP, HR)
* Demographic data (age, gender, ethnicity, socioeconomic status, geographical address)
* Answers to a lifestyle, attitudes, and health habits survey
* Answers to a program survey
* Contact information for follow up
Once the database is created a retrospective chart review will be done to collect data on patients that have completed the program. This information will be obtained from facility records and program records. Individuals who previously completed the program will be contacted and asked to provide consent to be included in the database. Only data from individuals who provide consent will be included in the database.
Participants in the program will be asked to provide consent when they enroll in the program or when they come for a follow up visit. Only data from individuals who provide consent will be included in the database.
Subjects will be followed to collect information on lifestyle maintenance and long term health outcomes.
The database will be queried regularly to provide information about the participants and program.
Descriptive statistics will be calculated to describe the study population pre and post program. Outcomes will be analyzed using appropriate statistical tests. Exploratory analysis will be conducted to detect trends.
Data will be stored in a secure location with limited access. All paper documents will be stored in a locked office in a locked cabinet. Electronic data will be stored on a limited access computer. The database will be password protected and encrypted.
All participants will be assigned a study ID number. The study ID will be used for transmission of data. Data collection forms will use the assigned study ID. All data that needs to be transmitted will be de-identified to the extent possible, password protected, and encrypted.
Conditions
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Study Design
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FAMILY_BASED
OTHER
Eligibility Criteria
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Inclusion Criteria
* participating family member
* able to understand English
6 Years
ALL
No
Sponsors
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Malia Shimokawa, MD
OTHER
Responsible Party
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Malia Shimokawa, MD
Medical Director, KMCWC Multidisciplinary Clinics
Principal Investigators
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Malia Shimokawa, MD
Role: PRINCIPAL_INVESTIGATOR
Kapiolani Medical Center For Women & Children
Locations
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Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Countries
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Other Identifiers
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2013-075
Identifier Type: -
Identifier Source: org_study_id
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